BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    ULTHERA SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799000286·

    IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ

    FDA 510(k)
    FDA Class 2 ·Hematology

    N-FORCE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 6, 2013

    ATB ADVANCE BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DQY·May 16, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 18, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·June 13, 2011

    NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·April 26, 2017

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 21, 2020

    BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·February 8, 2023